May 20, 2013 — InSightec Ltd. announced that the U.S. Centers for Medicare & Medicaid Services (CMS), a federal agency within the U.S. Department of Health and Human Services (HHS), has created a new billing code for magnetic resonance (MR) guided focused ultrasound treatment of pain palliation of metastatic bone lesions and has established a Medicare payment rate for hospital outpatient departments.

InSightec's ExAblate received U.S. Food and Drug Administration (FDA) approval for pain palliation of metastatic bone lesions in October 2012 and is the only MRgFUS system that is FDA approved for this indication. The approval was based on a two-arm randomized controlled trial comparing patients undergoing ExAblate MRgFUS for palliation of painful bone metastases with patients undergoing a placebo treatment.

According to the American Cancer Society, more than two-thirds of metastatic breast and prostate cancers and up to 30 percent of metastatic lung, bladder and thyroid cancers spread to the bones. Close to 30 percent of patients with bone metastases either do not respond to radiation therapy or will be unable to undergo radiation for pain relief. ExAblate provides a single session, non-invasive option that is highly effective with a low complication rates.

"We are extremely pleased with CMS' decision to provide a code and establish payment for MR guided focused ultrasound for bone metastases," said Kobi (Jackob) Vortman, president and chief executive officer of InSightec. "This is particularly important for the many cancer patients with crippling bone pain who are no longer eligible for radiation treatment. ExAblate is a safe and effective adjunctive treatment which enables patients to more quickly reduce their pain and their reliance on narcotic pain medications."

The new code, C9734, became effective April 1, 2013, and it was assigned to Ambulatory Payment Classification (APC) group 0067 (Level III Stereotactic Radiosurgery, MRgFUS and MEG).

ExAblate is the only MRgFUS system with FDA approval for pain palliation of bone metastases and for uterine fibroids. In addition, it has received European CE marking for uterine fibroids, bone metastases, benign bone tumors, adenomyosis, essential tremor, tremor-dominant Parkinson's disease and neuropathic pain. FDA approved clinical trials are ongoing for essential tremor, Parkinson's disease and prostate cancer.